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The Importance of
Advocacy to the Nuclear
Medicine Professional
Lynne Roy
Director, Imaging
Cedars Sinai Medical Center
PSWTC Spring Meeting, April 2016.
Objectives
To understand the current environment
that effect the nuclear medicine
profession
To learn about the Health Policy and
Regulatory Affairs Committee
To understand the importance of
involvement in advocacy
Discussion Topics
Education, Credentialing, Scope of
Practice and Actual Practice of NMTs
Reimbursement Pressures
Radiopharmaceutical Pressures
Radiopharmaceutical Availability
To learn about the SNMMI’s Health Policy
and Regulatory Affairs Department
Understand that you can make a difference
NMT Scope of Practice
Patients: care, contact, and monitoring
Radiopharmaceuticals: procurement, preparation, QC,
dispensing, dose calibration, administration, and
disposing
Adjunctive Pharmaceuticals: oral, iv, contrast
administration
Procedures: scanners, laboratory equipment, computers
Under Direction of an Authorized User
includes but is not limited to:
Educational Requirements for CNMTs
Certificate
High School graduate
College graduate
Assorted degrees (BS, BA)
Other related certificates (RT,RN)
Associate Degree
SNMMI: Baccalaureate Degree 2015
Educational/Program Certification
JRCNMT
• Establishes Essential Curriculum
• Added CT in 2010
• Considering MR
• Surveys and accredits programs
Has not mandated BS program as the minimum
With added essentials many AA programs take 4
years to complete full time
Nuclear Medicine Technologist
Certification
NMTCB Certifies Entry Level NMTS Offers advanced Cardiac, CT, and PET certifications
OJT recognized until 2016: Now accredited Program
ARRT certifies entry level NMTs Allows CNMTs to sit for ARRT (CT) and ARRT (MR)
Graduate of accredited program
Minimum AA
State Licensing BoardsNuclear Medicine (35 States)
Arizona Arkansas California
Colorado Connecticut Delaware
Florida Georgia Hawaii
Illinois Indiana Iowa
Kansas Kentucky Louisiana
Maine Maryland Massachusetts
Mississippi New Jersey New Mexico
New York North Dakota Ohio
Oregon Pennsylvania Rhode Island
South Carolina Texas Utah
Vermont Virginia Washington
West Virginia Wyoming
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Nuclear Medicine Technologists
Multiple educational pathways
Multiple Standards
Multiple State/National licensure (if any)
Multiple Professional Associations
U.S. Department of Labor: Trade or “paraprofessional”
◦ “You have muddied the waters”
◦ Multiple educational pathways
Multiple standards
State/National Licensure not required
Scope of Practice in Reality Patients: Monitoring? Care?
◦ RN
Radiopharmaceuticals: Preparation? Dispensing?
◦ Direct challenges by regulators
◦ Indirect due to fiscal realities of USP 797
Adjunctive Meds: ??? administer
◦ RN
◦ Hospitals Rules and Regulations
Procedures: More and more fusion equipment
◦ States licensing laws or lack there-of
Medical Imaging Target
for Decreased Reimbursement
• Prior authorization
• Appropriateness criteria
• Increased denials
Contiguous body parts
Accreditation of non-hospital
outpatient labs
Reduction in physician
reimbursement
Increase in equipment
utilization %
Continuous APC repackaging
Elimination of CPT codes
(bundled into “parent”)
Private Insurance CMS
Disparate Radiopharmaceutical
Regulations
USP 797
FDA
NRC
State Radiologic Departments
State’s Boards of Pharmacy
CMS
TJC
USP 797
Standards for all aspects of sterile
compounding Preparation of CSPs (compounded sterile products)
Personnel Requirements
Environmental and Room Requirements
Documentation
SOPs
FDA: Drug Quality and Security Act
Prepare drugs from FDA approved ingredients, according to package
insert or compendial methods
Pursuant to a physicians order or prescription for an individually
identified patient
Do not distribute an inordinate amount of drug across state lines.
Preparation of a FDA approved radiopharmaceutical pursuant to a
physicians order for an individual patient according to package insert
– is not considered compounding according to the law
Regulated by state boards of pharmacy
States, CMS, TJC
Licensing Requirements
Supervision Requirements
General
Direct
Personal
2004 TJC: Radiopharmaceuticals are drugs and as such,
come under direction of pharmacy
Pharmacy Directors and State BOD lack understanding of
unique issues
Is there really a 99m-TC Shortage
• Reactors end of life (20 years going on 50)
• Chalk River (NRU) Canada closing Oct 2016
• Highly Enriched Uranium (95%) *
• WMD
• Non-proliferation treaties
• Low Enriched Uranium (20%) **
• More radioactive waste
• Climate Change• Storms, volcanoes, and other disruptions to the fragile supply change
The Future of Moly Production
• Conversion of existing HEU reactors to LEU
• More reactors coming online using only LEU
• Alternative methods of nHEU-based Mo-99 production are in development by various entities• Production of Mo-99 (100Mo(y,n)99Mo) in accelerators, but material produced is
Low Specific Activity
• Neutron activation using Mo-98 (98Mo(n,y)99Mo) in reactors, but material produced is Low Specific Activity. (NorthStar)• Need a different generator due to LSA
• Producing using MURR
• Accelerator Driven fission process using LEU solution (Shine)• Can use current generator due to fissioned Mo-99 (HSA)
• Other recent (spring 2015) entrants• National Security Technologies/Global Medical Isotope Systems
• Coqui Pharma building a production facility in Florida
• * Fissioned U-235 Mo-99 is desirable due to HSA of Moly-99.
Radiation Awareness
Use of ionizing radiation has increased 72% in the last 30
years (CT and NM)
Publicity
FDA and CMS
Requires reporting of doses (CT, NM, fluoro)
Health Policy and
Regulatory Affairs (HPRA)
Collaborates with regulators, policymakers, and medical stakeholders to ensure nuclear medicine continues to be a valued part of the medical imaging community.
Due to the complexities of the field, policymakers and regulators are not aware of what the profession entails. We use advocacy to educate these decision makers so that they can make decisions beneficial to the nuclear medicine community and patient care.
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Government Affairs
Radiation Dose
Assessment Response
Medical Internal
Radiation Dose
Committee on
Radiopharmaceuticals
Joint Compounding
Task ForceAdvocacy
Coding &
Reimbursement
Coalition for PET
Drugs
FDA Task Force
Health Policy and Regulatory
Affairs - SNMMI Org Chart
Government Relations
Committee
Member/Board oversight of HPRA
Coordinates with other professional societies (ASRT, ARRT, ACR, etc).
Works with Coding and reimbursement to address policy needs with CMS legislation
Monitors and responds to issues at NRC, DOE, FDA and other federal agencies
Collaborates with Radiopharmaceutical Committee: Compounding, Isotope Production, Domestic Supply of M0-99.
Works with Advocacy on Grass Roots Issues
Coding and Reimbursement Committee
• Monitor, analyze, influence and disseminate information about
coding and reimbursement policies (e.g., CPT, ICD-9 and ICD-10,
HCPCS codes and APC)
• Provide coding and reimbursement education through the Coding
Corner
• Participate in the Practice Expense Committee of the AMA RUC and
the process to obtain appropriate codes, procedure descriptions and
reimbursement
• Work with stakeholders to obtain appropriate reimbursement for all
nuclear medicine resources, including radiopharmaceuticals in all
settings
• Work with CMS, Congress, local carriers and other medical societies
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Capitol Hill Day - May 2, 2016
SNMMI Delegation and Patient Advocates: Lobby Congress to urge CMS to adopt SNMMI’s alternative APC packaging which would ensure appropriate reimbursement for tracers/drugs and procedures
2015 Hill Day Participants
SNMMI’s APC Letter to
CMS
Committee on
Radiopharmaceuticals Liaise with Congress and government agencies to ensure a stable supply of isotopes
after 2016 deadline
Example: Mo-99 Availability
Congress – Implementation of American Medical Isotopes Production Act (AMIPA) 2011: To ensure a stable supply of Mo-99 before end of this year
U.S. Department of Energy - HEU phase-out
White House Working Group (OSTP, NNSA, FDA, CMS, NRC)
National Academy of Sciences presentations
OSTP - U.S. Office of Science and Technology Policy (part of the White House)
NNSA - U.S. National Nuclear Security Administration (part of the Department of
Energy)
CMS - Centers of Medicare and Medicaid Services (part of the Department of
Health and Human Services)
NRC - U.S. Nuclear Regulatory Commission
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FDA Task Force
Liaise with Congress and government agencies for faster approvals of new tracers/products
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– C-11 Choline - prostate
– R-82 Cardiogen - mpi
– Neuraceq (florbetaben) –Alzheimer’s
– Amyvid (florbetapir) –Alzheimer’s
– Vizamyl - (flutemetamol) -Alzheimer’s
– F-18 Sodium fluoride - bone
– N-13 Ammonia - mpi
– FDG – bone & glioblastoma
Drugs with NDAs filed:– Ga-68 DOTATATE
(neuroendocrine tumor imaging)
– F-18 DOPA (Parkinson’s)
– F-18 fluciclovine (prostate cancer)
Radiation Dose Assessment Response
Committee
Collaborate with regulatory agencies to ensure nuclear
medicine industry is a leader in radiation safety issues
Example: NRC
Patient release after treatment with I-131: NRC staff gaining
input from SNMMI on I-131 treatment procedures and best
practices on releasing I-131 patients
Part 35 Rule: Medical Use of Byproduct Material – Medical
event definitions, training and experience, and clarifying
amendments
Part 20 Rule: Standards for Protection Against Radiation
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Joint Compounding Task Force
Monitor and comment on federal and state compounding legislation in coordination with the Committee on Radiopharmaceuticals
Develop SNMMI official statements in relation to compounding policies for approval by the SNMMI Board of Directors
Create educational programs for compounding professionals who prepare radiopharmaceuticals (both for immediate use and bulk batch preparations)
Develop a white paper describing that properly trained and credentialed nuclear medicine technologists are compounding professionals
SNMMITS Advocacy Committee
Scope of Practice Committee
Aligns SNMMITS
documents to the CNMT
SOP
Aligns other professional
societies’ documents to
the CNMT SOP
Updates current SOP to
include changes: PET, CT.. MRI is coming
Lobbies agencies to allow
SOP
Technologist Advocacy
Group
State focused
Monitor state activities land policy changes impacting CNMTs
Updates members regarding changes to state regulations
Responds to CNMT inquiries
Meetings, Letters, and a Well
Defended SOP Consensus Statement for PET/CT
All major professional societies RTs and CNMTs can with specified training
TJC: removed requirement for DIRECT supervision of radiopharmaceutical preparation
CMS: removed DIRECT supervision from CoP
Radiation Control Officers via CRCPD:◦ Part Z: Defined necessary training/certification for diagnostic CT scans
◦ Anyone, explicitly CNMTs with a CT certification
TJC: Any one who performs CT must be certified in CT by ARRT or NMTCB Implicit recognition that CNMTs can perform CT scans
What is a TAG and What Do They Do?
Dedicated members in each state who are involved
at the local level. Identify changes in state laws/regulations concerning the
practice of nuclear medicine
Address any concerns or questions submitted by
SNMMI-TS members from their state
Keep aware of all other news or policy changes that
might affect SNMMI’s technologists
Six vacancies (Colorado, D.C., Florida, Minnesota, New
Hampshire, West Virginia)
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TAGs Need to Know
Modalities that are licensed in State
State requirements regarding a state licensing exam in
addition to or in lieu of certification
The licensing term in State (2 years, 5 years, etc.)
CNMT certifications that are recognized in state (NMTCB,
ARRT)
The State’s Continuing Education requirement?
The name of the head of the Radiation Control Program
The name of the state’s Conference of Radiation
Control Program Directors (CRCPD) and contact
information?
Names of the Assembly Speaker and Head of the State
Senate
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Watching Your Back By Monitoring
State Legislation New Jersey did not allow CNMTs to operate ANY CT portion of
hybrid equipment TAG: CNMTs can now operate hybrid equipment for attenuation and
anatomical localization.
California did not allow CNMTs to perform diagnostic CT scans on hybrid equipment TAG: CNMTs with CT certification are now allowed to fully operate the CT
portion of a hybrid system including performance of diagnostic CTs.
Arizona did not allow CNMTs to perform diagnostic CT scan on hybrid equipment TAG: CNMTs with CT certification are now allowed to perform CT scans on
hybrid and stand-alone CT scanners.
Mississippi regulation was about to severely limit a CNMTs SOP TAG: Stopped bill in Senate, reversed unfavorable language and added CT
and adjunctive administration to existing SOP
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PSWTC TAG Contact or Ask a Question
Contact information for other TAGs can be found
at: www.snmmi.org/TAGmembers
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Arizona NevadaJeanne Dial, Med,CNMT,RSO Frank Talbot, MBA, CNMT, PET,
ARRT (N) (R) Tahoe Forest Hospital District
Gateway Community College Nuc Med/PET
602-286-8512 530-582-3434
dial@gatewaycc.edu FTalbot@tdhd.com
California
Lynne Roy, MBA, CNMT, FSNMMITS
Cedars Sinai Medical Center
Department of Imaging
310-423-4203
Roy@cshs.org
How TAGs Remain “In The Know”
They Sign up for SCOUTFree service (search engine) that provides information
about regulations and legislation introduced or pending
Washington, DC and State Capitols
Sends custom alerts on designated terms appearing in: Congressional Bills
State Bills
Federal Regulations
Congressional Hearings
https://scout.sunlightfoundation.com
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Scout45
Visit the Scout website and find the search box
Click on advanced and enter your search term
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